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. 2021 Jul-Aug;14(4):965-973.
doi: 10.1016/j.brs.2021.05.012. Epub 2021 Jun 13.

Seizure risk with repetitive TMS: Survey results from over a half-million treatment sessions

Joseph J Taylor  1 , Noam G Newberger  2 , Adam P Stern  3 , Angela Phillips  4 , David Feifel  5 , Rebecca A Betensky  6 , Daniel Z Press  7
Affiliations
Free article

Seizure risk with repetitive TMS: Survey results from over a half-million treatment sessions

Joseph J Taylor et al. Brain Stimul. 2021 Jul-Aug.
Free article

Abstract

Background: Seizures are rare during repetitive transcranial magnetic stimulation (rTMS) treatment, but estimating risk is difficult because of study heterogeneity and sampling limitations. Moreover, there are few studies comparing rates between device manufacturers.

Objective: The objective of this study was to calculate rTMS seizure rates across various FDA-cleared devices in naturalistic clinical settings.

Methods: In July and August 2018, approximately 500 members of the Clinical TMS Society (CTMSS) were electronically surveyed about seizures in their practices. Seizures were distinguished from non-seizures by a remote semi-structured interview with a Board-certified neurologist and Co-Chair of the CTMSS Standards Committee. Exact Poisson calculations were used to estimate seizure rates and confidence intervals across the four most widely used manufacturers.

Results: The survey was completed by 134 members, with 9 responses excluded because of data inconsistencies. In total, 18 seizures were reported in 586,656 sessions and 25,526 patients across all device manufacturers. The overall seizure rate was 0.31 (95% CI: 0.18, 0.48) per 10,000 sessions, and 0.71 (95% CI: 0.42, 1.11) per 1000 patients. The Brainsway H-coil seizure rate of 5.56 per 1000 patients (95% CI: 2.77,9.95) was significantly higher (p < 0.001) than the three most widely used figure- 8 coil devices' combined seizure rate of 0.14 per 1000 patients (95% CI: 0.01, 0.51).

Conclusion: The absolute risk of a seizure with rTMS is low, but generic Brainsway H-coil treatment appears to be associated with a higher relative risk than generic figure- 8 coil treatment. Well-designed prospective studies are warranted to further investigate this risk.

Keywords: Interventional psychiatry; Risk; Safety; Seizure; Transcranial magnetic stimulation.

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Conflict of interest statement

Declaration of competing interest JT: I have no conflicts of interest. Part of my time was supported by the Sidney R. Baer, Jr. Foundation. NN: I have no conflicts of interest. AS: I have no conflicts of interest. Part of my time during the era of data collection was supported by the Brain and Behavior Research Foundation's Young Investigator Award as well as the Harvard Catalyst/The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic centers. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Catalyst, Harvard University and its affiliated academic healthcare centers, or the National Institutes of Health. AP: I have no conflicts of interest. DF: I serve on the Scientific Advisory Board for Brainsway. RB: I have no conflicts of interest. DP: I have no conflicts of interest.

Comment in

  • Irregularities and misrepresentations of a survey by Taylor et al.
    Tendler A, Zibman S, Pell GS, Krieger AM. Tendler A, et al. Brain Stimul. 2021 Sep-Oct;14(5):1087-1088. doi: 10.1016/j.brs.2021.07.016. Epub 2021 Jul 27. Brain Stimul. 2021. PMID: 34329795 No abstract available.
  • Reply to Tendler et al.
    Taylor JJ, Newberger NG, Stern AP, Phillips A, Feifel D, Betensky RA, Press DZ. Taylor JJ, et al. Brain Stimul. 2021 Sep-Oct;14(5):1216-1217. doi: 10.1016/j.brs.2021.08.012. Epub 2021 Aug 13. Brain Stimul. 2021. PMID: 34400377 No abstract available.

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